Leverage from factory acceptance test, site acceptance test, and commissioning into qualifications using a filler of a packaging line as a model in the pharmaceutical industry

Abstract

The leverage process from Factory Acceptance Test, Site Acceptance Test, and Commissioning into Qualification was evaluated to identify the components required and the regulatory requirements currently available. After the evaluation performed, a functional unit of a pharmaceutical industry was used as a prototype or model to perform the leverage process. A filler machine was selected since it is commonly used in the pharmaceutical industry. A total of 32 tests for commissioning and for qualification were developed. From the 32 tests, 13 IQ tests were leveraged for a 41% which represent a cost saving of 28% of the qualification and $650.00 less in the total execution cost. Therefore, the time taken to have the filler machine qualified can be traduced about 28% less of the time expected to complete the qualification exercise of the packaging line Therefore, it can be concluded based on the previous analysis that the leverage process reduces times and costs during the execution of the project, and accelerates the delivery of the product on time to the end user in this competitive environment of the pharmaceutical industry.